Rare diseases
Investigational molecules
Locations
Bone marrow-derived mesenchymal stem cells (BM-MSCs) are a type of cell therapy. They are made from mesenchymal stem cells taken from adult human bone marrow and expanded outside the body in a laboratory.[2] The product used in the registered trial is called StromaForte MSC solution for infusion.[1] The substance is classified as a cell therapy of structurally diverse origin. It has no marketing authorisation in the product records and is therefore an investigational substance.[1] The European Medicines Agency (EMA) has classified a similar product of ex-vivo expanded adult human bone-marrow derived pooled allogeneic mesenchymal stromal cells as a somatic cell therapy medicinal product.[2]
Mesenchymal stem cells are thought to act through immunological and trophic mechanisms, meaning they may influence the immune system and support tissue repair.[2] Research in laboratory models suggests that bone marrow mesenchymal stem cells can affect the polarization of macrophages, a type of immune cell, which may be one way they modulate inflammation and healing.[3] The exact way these cells work in human disease is still being studied.
The registered clinical trial does not specify a particular condition; it is a safety study in a general population.[1] A related product has been proposed for use in thromboangiitis obliterans (Buerger’s disease), a rare condition that affects blood vessels in the arms and legs.[2]
The product is given as a cell suspension for injection by intravenous infusion, meaning it is dripped directly into a vein.[1] In the registered trial, the dose was 5 million cells per infusion.[1]
There is one registered clinical trial in the EU Clinical Trials Information System. The trial, 2024-517011-74-01, is completed and enrolled 200 participants.[1] It is described as a low intervention study, meaning the treatment is given in addition to usual care with minimal additional burden.[1] The primary outcome is the rate of adverse events and serious adverse events, including clinically significant laboratory abnormalities.[1] The trial was designed to evaluate the long-term safety of treatment with Cellcolabs-produced mesenchymal stem cells.[1]
The completed trial measured adverse events and serious adverse events as its main outcome, but the results are not described in the available registry data.[1] The supplementary sources do not list specific side effects for this product.
Each condition opens its own overview and trial list
Recruiting trials first
Tell us about your condition – we search every trial in Europe and connect you with the right site.
